Biosimilar Epoetin Zeta in Oncology and Haematology: Development and Experience following 6 Years of Use

Chemotherapy-induced anaemia is frequent in cancer patients, with severity depending on the extent of the disease and intensity of treatment. Clinical guidelines recommend erythropoietin therapy to treat or prevent anaemia in some oncology/haematology patients being treated with chemotherapy. The patent expiry of the first-generation erythropoietins has led to the development of biosimilar products, i.e. therapeutic proteins exhibiting comparable quality, safety and efficacy to an existing reference biological medicine, the patent of which has expired. This review summarises the available data set supporting the use of one such biosimilar product, epoetin zeta (Retacrit (TM)) in oncology/haematology. The body of evidence supporting the use of epoetin zeta continues to grow, with post-marketing clinical studies underway to evaluate its longer-term clinical efficacy and safety. Biosimilar medicines have the potential to offer cost savings to health care providers, with the assurance of ongoing risk management programmes to ensure patient safety. (C) 2015 The Author(s) Published by S. Karger AG, Basel